After coming under a lot of criticism from various quarters over lack of response to logjam in regulations, the union cabinet has given a green signal for massive overhaul of drug regulatory infrastructure

India wants more! Govt in its 2015-16 budget, had allocated Rs 29,700 crore for the health sector which is still 2 percent of overall allocations.

On August 12, 2015, the cabinet committee on economic affairs (CCEA), chaired by the Prime Minister, Mr Narendra Modi, approved the proposal for strengthening the drug regulatory system both at the central and the state levels at a total cost of Rs 1750 crore.

The note from Press Information Bureau stated that the strengthening or up-gradation of the system will be spread over a period of three years. Out of the total amount of Rs 1750 crore, an amount of Rs 900 crore will be spent on strengthening central structures that mainly includes the Central Drug Standards Organization (CDSCO). The rest of Rs 850 crore will be made available to the state governments, after signing a Memorandum of Understanding.

During his exclusive chat with BioSpectrum a few months back, Dr G N Singh, drug controller general of India (DGCI) had hinted at a revamp in offing. "2015 is going to be a year of streamlined regulations. The industry is upgrading its capacity and skills. Capacity building is a major thrust of the government of India when we are going to have the regulatory frameworks, tools, setups in place. We intend to graduate to the next level and in 2-3 years, we would be better placed. The government has taken proactive steps. We had the strength of 40 inspectors in 2008 and now it has gone upto 347. There will be the addition of 200 more in next 2 years. The basic issue is to train them as per current national and international expectations. Government is supporting us the regulations stringent yet streamlined'" he had commented.

Industry terms it positive step

In his first reaction, Dr P M Murali, president, Association of Biotechnology Led Enterprises (ABLE) expressed utmost pleasure at this decision. "ABLE is delighted to understand that the Prime Minister has decided to allocate 1750 crores for regulatory matters. This is the most forward looking activity done by any government in the past two decades. A much needed investment and the Industry is thankful," he told BioSpectrum.